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ND0612
ND0612 is a subcutaneous infusion formulation of levodopa/carbidopa that continuously delivers dopamine precursor to the brain to treat motor symptoms of Parkinson's disease.
ND0612 is a subcutaneous infusion formulation of levodopa/carbidopa that continuously delivers dopamine precursor to the brain to treat motor symptoms of Parkinson's disease. Used for Parkinson's disease with motor fluctuations in patients not adequately controlled by oral levodopa therapy.
At a glance
| Generic name | ND0612 |
|---|---|
| Also known as | Levodopa/Carbidopa solution, (Levodopa-Carbidopa solution), ND0612H |
| Sponsor | NeuroDerm Ltd. |
| Drug class | Dopamine precursor (levodopa) combination therapy |
| Target | Dopamine pathway; levodopa is converted to dopamine via aromatic amino acid decarboxylase |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
ND0612 provides continuous subcutaneous delivery of levodopa (converted to dopamine) and carbidopa (a decarboxylase inhibitor that prevents peripheral conversion of levodopa) via a portable pump. This continuous delivery approach aims to reduce motor fluctuations and dyskinesia compared to oral dosing by maintaining more stable dopamine levels in the brain throughout the day.
Approved indications
- Parkinson's disease with motor fluctuations in patients not adequately controlled by oral levodopa therapy
Common side effects
- Injection site reactions
- Nausea
- Dyskinesia
- Dizziness
- Hallucinations
Key clinical trials
- A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease (PHASE2)
- Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (PHASE3)
- A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients (PHASE1)
- A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients (PHASE1)
- A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects (PHASE1)
- Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers (PHASE1)
- A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 (PHASE2)
- A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's Disease (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ND0612 CI brief — competitive landscape report
- ND0612 updates RSS · CI watch RSS
- NeuroDerm Ltd. portfolio CI